Cleared Traditional

K771324 - 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID

K771324 is an FDA 510(k) clearance for 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID, manufactured by Corning Medical & Scientific. The device is a Class 2 Chemistry device with product code JHX cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K771324 · Corning Medical & Scientific · Chemistry device

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Sep 1977

Decision

46d

Days

Class 2

Risk

K771324 is an FDA 510(k) clearance for the 3-(N-MORPHOLINS)-PROPANE SULFONIC ACID. Classified as Fluorometric Method, Cpk Or Isoenzymes (product code JHX), Class II - Special Controls.

Submitted by Corning Medical & Scientific (Mchenry, US). The FDA issued a Cleared decision on September 2, 1977 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1215 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K771324

510(k) Number	K771324 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 18, 1977
Decision Date	September 02, 1977
Days to Decision	46 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

43d faster than avg

Panel avg: 89d · This submission: 46d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

JHX Device Classification - Class 2, Special Controls

Product Code	JHX Fluorometric Method, Cpk Or Isoenzymes
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 862.1215

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.

Regulatory Peers - JHX Fluorometric Method, Cpk Or Isoenzymes

All 47

Devices cleared under the same product code (JHX) and FDA review panel - the closest regulatory comparables to K771324.

CARDIO CK-B RIA KIT

K791582 · Nuclear Medical Systems, Inc. · Nov 1979

BUFFER, CORNING MOPSO

K790294 · Corning Medical & Scientific · Mar 1979

CREATINE KINASE ISOENZYME SUBSTRATE SET

K771605 · Pfizer Pharmaceuticals · Sep 1977

SIGMA PROCEDURE NO. 745 - EP.REAGENT SY

K760591 · Sigma Chemical Co. · Oct 1976

FDA 510(k) Resources - Chemistry

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K771324

Corning Medical & Scientific

Mchenry, IL · US

Regulatory profile

111 submissions 111 cleared

100% clearance rate · Active in Chemistry

View all devices by Corning Medical & Scientific →

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: September 2, 1977. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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510k Database

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FDA monthly sync November 6, 2026